Spravato: New Ketamine Treatment to be Approved by FDA

Last week a committee of the U.S. Food and Drug Administration (FDA) recommended in a 14-2 vote that the agency approve the use of a nasal spray form of esketamine (a specific type of ketamine) for the treatment of treatment-resistant depression and certain other types of depression.

Treatment-resistant depression is when clinical depression fails to respond to multiple (at least two) attempts to treat it with at least two different types of medications or psychotherapy over the course of a year or longer.

If the FDA ends up approving the drug — and we believe they will — it will offer new hope for people with depression.

Ketamine has more recently been prescribed off-label for the treatment of depression at high-priced “ketamine clinics.” Such clinics regularly charge people $650 – $1200 per treatment, with most people needing 6 to 8 treatments to get started. Most insurance won’t cover the cost of this treatment, since depression is not a condition that ketamine is currently approved to treat.

The Good News

The new drug is named Spravato, an intranasal form of esketamine, and is made by Janssen, a division of Johnson & Johnson. Eventual FDA approval of this type of ketamine treatment would make such treatment far more affordable to more people.

The committee determined that Spravato has a favorable benefit-risk profile, after analyzing the safety and efficacy data from five different research studies conducted in patients with treatment-resistant depression. The research showed that esketamine delivered through a nasal spray, alongside a traditional oral antidepressant, provided statistically significant improvement of symptoms associated with depression.

Historically the FDA rarely goes against the advice of its Psychopharmacologic Drug Advisory Committee. A source within the FDA has suggested to me that the FDA will approve the drug for these specific conditions.

The FDA fast-tracked approval of this drug, because it is already approved for use for other medical needs as an anaesthetic. Therefore, its safety profile is also well understood. The FDA calls this fast-track process a “breakthrough therapy” designation.

The FDA committee has also approved Spravato for the indication of major depressive disorder in people who are at an imminent risk for suicide.

The Bad News

In their typically paternalistic manner, the FDA committee didn’t think patients could be entrusted to take the drug as directed on their own. One of the side effects after administration of the drug is dissociation and sedation. Obviously you wouldn’t want someone to take a dose of this drug, and then go and operate heavy machinery.

So the committee is recommending that the FDA not let you take the nasal spray at home, according to Vantage:

The agency has proposed a risk-evaluation and mitigation strategy that requires self-administration in a healthcare facility that can monitor patients for two hours, until dissociative and sedation side effects have subsided, as well as a patient registry that could help characterize the project’s risk.

That means for every treatment, a patient is still going to need to make an appointment with their medication provider and hang around the office (?) for two hours (??!) after they’ve taken the drug. This is a weird recommendation and could dampen people’s desire to give the drug a try. I hope the final FDA approval makes the program more flexible and take into consideration the diverse set of people who suffer from depression, since these requirements would impact low-income people the most.

But this is in keeping with how ketamine clinics currently operation. There, ketamine is delivered as an intravenous infusion (IV) directly into the blood stream. The patient gets the infusion, then they need to stick around for approximately an hour to ensure they can be monitored for negative side effects.

Infusions also allow the drug to bypass processing by the liver and other organs. Intranasal sprays allow for the same kind of bypass, making it easier to offer the drug at lower doses while maintaining its efficacy. Additionally, because no IV is needed, it is expected that Spravato will be offered at a more affordable price than current ketamine treatments for depression do. It remains to be seen how the

I hope Janssen prices this drug affordably enough that most ordinary Americans can have access to it. Today, most Americans cannot afford the price of admission at ketamine clinics. I also urge health insurance companies to immediately approve coverage of this drug on all of their offered health plans for the specific approved conditions, because it may be a game changer in terms of helping people feel better from severe depressive symptoms.

The FDA is set to make its decision by March 4, 2019. We hope the agency does right by the million+ Americans who suffer from treatment-resistant and other kinds of difficult depression. We also hope that the agency minimizes treatment barriers — such as requiring a doctor’s office visit — to obtain this important treatment for depression.

For more information

From Vantage: Esketamine floats past adcom vote

From The Pharma Letter: J&J nasal spray set to win first approval in ketamine-based depression research

from World of Psychology https://psychcentral.com/blog/spravato-new-ketamine-treatment-to-be-approved-by-fda/